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Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)

ConditionsGynecologic CancerRadiotherapy Side EffectRadiotherapy; ComplicationsSurvivorshipProgression, DiseaseProgression, Clinical
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-90
SponsorIRCCS San Raffaele

About this trial

This is an observational mono-institutional study. Patients with gynecologic tumors treated with advanced radiotherapy- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- will be included and toxicity and outcomes analyzed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

gynecologic cancer patients

>18 years old

treated with advanced radiotherapy techniques (IGRT, IMRT, SBRT)

Disqualifiers

other tumors

> 90 years old

Trial population

Gynecologic cancer patients, \> 18 years old, treated with IGRT, IMRT, SBRT

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Image Guided Radiotherapy

    Radiation

    Patients treated with IGRT, IMRT, SBRT for Gynecological cancer will be evaluated

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Gynecologic cancer patients1 intervention

Trial outcomes

Primary outcomes

1

Local Relapse Free Survival

local control (on the treated site) of the disease

Time frame
From date of radiotherapy end until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
2

Regional Relapse Free Survival

regional control (regional lymph nodal chain) of the disease

Time frame
From date of radiotherapy end until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
3

Distant Metastases Free Survival

distant metastases developed after the treatment

Time frame
From date of radiotherapy end until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
4

Disease Free Survival

absence of disease progression during the follow-up

Time frame
From date of radiotherapy end until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

Secondary outcomes

1

Acute toxicity

Toxicity developed in the first three months after the treatment, assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale, which displayes grades from 1 to 5, with grade 1 meaning mild toxicity and grade 5 death related to toxicity

Time frame
Up to three months from the start of radiotherapy
2

Late toxicity

Toxicity developed after three months until the end of follow-up or death, assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale, assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale, which displayes grades from 1 to 5, with grade 1 meaning mild toxicity and grade 5 death related to toxicity

Time frame
From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months

Other outcomes

1

Predictive factors for disease progression and death

Factors predicting survival. Survival trees, univariate/multivariate Cox regression models will be estimated to identify potential risk factors associated with survival outcomes

Time frame
From radiotherapy end to date of local, regional progression, distant failure, or death, assessed up to 120 months
2

Radiomic predictive factors for disease progression and death

CT and PET/CT radiomic features predicting relapse or death will be extracted, acording to IBSI (Image Biomarker Standardisation Initiative), owning to the different families of features: Morphology, Statistical, Intensity Histogram, Grey Level Cooccurrence Matrix 3D-average, Grey Level Co-occurrence Matrix 3D-combined, Grey Level Run Lenght 3D-average. Grey Level Run Lenght 3D\_combined, Grey Level Size Zone Matrix 3D, Neighbors Grey Tone Difference Matrix 3D, Grey Level Distance Zone Matrix 3D, standard convolutional filters within radiomic workflow (wavelets, Laplacian of Gaussian)

Time frame
From radiotherapy end to the first registered event (disease progression or death), assessed up to 120 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS San Raffaele

Lead sponsor

Source ClinicalTrials.gov
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